Amcinonide Ointment

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Amcinonide Ointment is Amcinonide in a suitable ointment base. It contains NLT 90.0% and NMT 115.0% of the labeled amount of amcinonide (C₂₈H₃₅FO₇).

2 IDENTIFICATION

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A. The retention time of the amcinonide peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-Aug-2019)

3 ASSAY

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3.1 Procedure

Solution A: Acetonitrile and water (35:65) (USP 1-Aug-2019)

Solution B: Acetonitrile and water (70:30) (USP 1-Aug-2019)

Mobile phase: See Table 1. Equilibrate the system with Solution A.

Table 1

Diluent: Acetonitrile and chloroform (80:20)

System suitability solution: 12.5 μg/mL of USP Butylparaben RS (USP 1-Aug-2019) and 20 μg/mL of USP Amcinonide RS in Solution B

Standard solution: 0.02 mg/mL of USP Amcinonide RS in Solution B

Sample stock solution: Nominally 0.2 mg/mL of amcinonide prepared as follows. Dissolve a suitable amount of Ointment in a suitable volume of Diluent in a volumetric flask (USP 1-Aug-2019) by heating in a hot water bath, cooling, and diluting with Diluent to volume. Cool to room temperature, dilute with acetonitrile to volume, and filter.

Sample solution: Nominally 0.02 mg/mL of amcinonide in Solution B from the Sample stock solution

3.2 Chromatographic system

Mode: LC

Detector: UV 240 nm

Column: 4.6-mm × 25-cm; 5-μm (USP 1-Aug-2019) packing L1

Flow rate: 2 mL/min

Injection volume: 10 μL

3.3 System suitability

Samples: System suitability solution and Standard solution

[Note- The relative retention times for butylparaben and amcinonide are 0.78 and 1.0, respectively.]

3.4 Suitability requirements

Resolution: NLT 8.0 between butylparaben and amcinonide, System suitability solution

Tailing factor: NMT 1.5, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

3.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of amcinonide (C₂₈H₃₅FO₇) in the portion of Ointment taken:

Result = (r_u/r_s) × (C_s/C_u) × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of USP Amcinonide RS in the Standard solution (mg/mL)

C_u = nominal concentration of amcinonide in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–115.0%

4 PERFORMANCE TESTS

Minimum Fill 〈755〉: Meets the requirements

5 SPECIFIC TESTS

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Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉: The total aerobic microbial count is NMT 102 cfu/g and the total yeasts and molds count is NMT 101 cfu/g. (USP 1-Aug-2019) Meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa

6 ADDITIONAL REQUIREMENTS

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Packaging and Storage: Preserve in tight containers. Store at controlled room temperature. (USP 1-Aug-2019)

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USP Reference Standards 〈11〉

USP Amcinonide RS

USP Butylparaben RS